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Director, R&D Quality, Global RD/PV QA - Trenton, United States - Daiichi Sankyo
Description
Join a Legacy of Innovation 110 Years and CountingDaiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology.
With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
Under the Group's 2025 Vision to become a "Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders.
SummaryLead the implementation of the quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units.
Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA.
Within assigned GPTs, facilitate the implementation of a risk-based quality management process fully embedded through trial design, execution and submission including all vendor managed business setups with the objective of achieving the highest data quality standards, full adherence to patient's rights and well-being and in support of successful Health Authority inspections and approvals.
Lead in a proactive and strategic way and through collaboration with other GxP Quality representatives, act as QA point person for all GxP matters for the Global Program Head and the Global Program Team.
Provide operational QA leadership for the respective GPTs, including Quality Oversight for the Quality Plan execution, Health Authority Commitments, Critical Incidents including, respective escalation process and the CAPA Management Process for the respective business areas.
ResponsibilitiesFacilitate the implementation of the quality strategy in close alignment with the GPT business strategy.
Monitor and track implementation and break-down of the Quality Manual into an annual Quality Plan together with the supported GPTs including the quality risk assessments and inspection readiness components for the designated programs.
Ensure proactive representation of Quality professionals at strategic project team and at GCP strategic discussions.Support the Head of RD QA with Quality Reviews of respective product profile to ensure appropriate management review of all quality and compliance related topics including the review of Key Quality Indicators (KQIs).
Identify appropriate continuous improvement initiatives for quality and compliance related areas. Deputize for the Head of RD QA at the Development Leadership teams, as appropriate and as neededInteract with senior Oncology Franchise leadership teams to ensure Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management process.
Interact with the audit function.The respective Data Management groups and respective CROs in order to ensure high data quality and proactive detection and resolution of issues.
Lead effective communications within the GPT, by interacting with other GxP QA functions (GMP/ IMP QA, Audit Compliance, Quality Management System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager.), on GxP topics/issues impacting the respective clinical programs.
Help to ensure in collaboration with Global Development Operations (GDO) (Global Clinical Operations / Clinical Quality Management or other RD business process owners that applicable clinical development processes and quality standards which are in line with worldwide HA requirements are implemented.
Help to establish in-built controls in relevant process steps to ensure adherence to regulatory compliance.Monitor effectiveness of implementation of applicable clinical development processes through KQIs in collaboration with business process owners to demonstrate that processes are in control and ensure required compliance levels.
Implement and lead the process to regularly review and assess KQIs at the respective GPTs and prepare respective management documentation for the QA Head for review at the Quality Leadership level and Development Leadership level/ governance teams.
Ensure that potential gaps and risks are addressed and opportunities for continuous improvement identified.Quality Oversight:
Ensure adequate and timely escalation of incidents/issues within GPTs and QA.
In collaboration with GxP CAPA Leads, provide Quality oversight for deviations/incidents investigations and ensure that adequate CAPAs are defined, implemented and their closure tracked.
Ensure that proper Quality oversight is implemented within the GPTs for 3rd parties/vendors/outsourced activities. Provide oversight over the implementation of CAPA effectiveness checks.Share quality status information to business functions is a timely manner at appropriate forums (e.g., OPL forums, regional forums, other RD governances), including the support of creating and reviewing quality metrics for the Quarterly Quality Report (QQR) and Clinical Quality Review Boards (cQRBs).
Ensure continued submission and inspection readiness for the respective GPTs and related submissions. Facilitate respective regulatory inspection preparation, management and follow-up in collaboration with business functions. Support local inspections with adequate systems and process support.Support through open and effective communication and business partnering the cross-functional implementation of the Strategy, and Vision and Mission of Global RD/PV QA.
Drive a culture of solution oriented and evidence-based mind-set with openness for innovative ways of working and new technologies.Lead Lessons learned information flow at the GPT/ Clinical Operations level based on audits, inspections, regulatory intelligence, effectiveness checks and process improvement.
Qualifications:
Successful candidates will be able to meet the qualifications below with or without a reasonable accommodation.
Education Qualifications (from an accredited college or university)
10+ years of professional experience in regulated activities, clinical development and QA (preferably) leadership positions, or equivalent experience required
10+ years of demonstrated knowledge understanding of global expectations of Health Authorities in the area of Clinical Development
Must possess a profound understanding of the science of product development
Demonstrated accomplishments working within a global/matrix environment in the pharmaceutical industry.
Must have expertise in leading/managing (Global) projects.
Must possess strong leadership, interpersonal, communication, negotiation and problem-solving skills.
Must have ability to work independently and in a team environment.
Proven track record of successfully leading projects with high impact. preferred
Ability to effectively interact with and present to senior management at all levels, as well as to external audiences and inspectors.
Demonstrated organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross- functionally and in global teams.Strong Industry Network in clinical development. Knowledge and understanding of cultural differences and diversity issues
Strong written and oral communication skills (English)
Travel
Must have ability to travel up to 30%
Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer.
Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.
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